(72 days)
The Aspira* Peritoneal Drainage System is indicated for intermittent drainage of recurrent and symptomatic malignant ascites. The catheter is intended for long-term access of the perioneal cavity in order to relieve symptoms such as dyspnea or other symptoms associated with malignant ascites.
The Aspira* Drainage Bag is indicated for use only with the Aspira* Drainage Catheter for intermittent drainage.
The Aspira* Dressing Kit is indicated for dressing of a catheter and exit site.
The Aspira* Luer Adapter is intended to provide access to the Aspira* Drainage Catheter. It is used to drain fluid using standard wall suction, water seal drainage system, glass vacuum bottle, syringe or other appropriate method.
The Aspira* Valve Assembly attaches to the Aspira* Drainage Catherer. The Aspira* Repair Kit is for the repair of the Aspira* Drainage Catheter and replacement of the Aspira* Valve Assembly.
The Aspira* Peritoneal Drainage System is designed for long-term intermittent drainage of recurrent and symptomatic malignant ascites. The Aspira* Peritoneal Drainage System provides patients with a convenient method to relieve malignant ascites symptoms at home. The primary components of the system are the Aspira* Periloncal Drainage Catheter and the Aspira* Drainage Bag.
The Aspira* Peritoneal Drainage Catheter is a long-term indwelling silicone catheter used to drain accumulated fluid from the perioncal cavity to relieve symptoms associated with malignant ascites. The fenestrated catheter is placed in the patient's abdominal cavity enabling the patient or caregiver to perform intermittent drainage of their malignant ascites at home.
The Aspira* Drainage Bag is used to collect peritoneal fluid by gravity. The drainage bag attaches to the placed catheter and is activated using an in-line silicone pump.
The Aspira* Luer Adapter is designed to access the Aspira* Drainage Catheter. The lucr adapter is connected to wall suction or a syringe to perform intermittent drainage or catheter maintenance.
The Aspira* Valve assembly attaches to the proximal end of the Aspira* Drainage Catheter to prevent fluid or air exchange through the catheter when not in use.
The provided document is a 510(k) premarket notification letter and summary for the Aspira Peritoneal Drainage System. This type of document is for demonstrating substantial equivalence to a legally marketed predicate device, not for providing acceptance criteria and study results for a new device's performance.
Therefore, the document does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically:
- A table of acceptance criteria and reported device performance
- Sample size used for the test set and data provenance
- Number of experts used to establish ground truth and their qualifications
- Adjudication method
- Multi-reader multi-case (MRMC) comparative effectiveness study results
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
The document focuses on the device description, its intended use and indications for use, and a technological comparison to a predicate device (PLEURX™ Peritoneal Catheter Kit and PLEURX™ Drainage Kit) to argue for substantial equivalence. It does not detail specific performance studies with quantitative acceptance criteria for the Aspira Peritoneal Drainage System itself.
§ 876.5630 Peritoneal dialysis system and accessories.
(a)
Identification. (1) A peritoneal dialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions, and that consists of a peritoneal access device, an administration set for peritoneal dialysis, a source of dialysate, and, in some cases, a water purification mechanism. After the dialysate is instilled into the patient's peritoneal cavity, it is allowed to dwell there so that undesirable substances from the patient's blood pass through the lining membrane of the peritoneal cavity into this dialysate. These substances are then removed when the dialysate is drained from the patient. The peritoneal dialysis system may regulate and monitor the dialysate temperature, volume, and delivery rate together with the time course of each cycle of filling, dwell time, and draining of the peritoneal cavity or manual controls may be used. This generic device includes the semiautomatic and the automatic peritoneal delivery system.(2) The peritoneal access device is a flexible tube that is implanted through the abdominal wall into the peritoneal cavity and that may have attached cuffs to provide anchoring and a skin seal. The device is either a single use peritioneal catheter, intended to remain in the peritoneal cavity for less than 30 days, or a long term peritoneal catheter. Accessories include stylets and trocars to aid in the insertion of the catheter and an obturator to maintain the patency of the surgical fistula in the abdominal wall between treatments.
(3) The disposable administration set for peritoneal dialysis consists of tubing, an optional reservoir bag, and appropriate connectors. It may include a peritoneal dialysate filter to trap and remove contaminating particles.
(4) The source of dialysate may be sterile prepackaged dialysate (for semiautomatic peritoneal dialysate delivery systems or “cycler systems”) or dialysate prepared from dialysate concentrate and sterile purified water (for automatic peritoneal dialysate delivery systems or “reverse osmosis” systems). Prepackaged dialysate intended for use with either of the peritoneal dialysate delivery systems is regulated by FDA as a drug.
(b)
Classification. Class II (special controls). The following accessories are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9: A catheter finger grip that is non-patient contacting and intended for single use with a peritoneal catheter; a continuous ambulatory peritoneal dialysis (CAPD) belt; and a catheter stand that does not include weigh scales.